Phase II/III Study of the Tolerance and Efficacy of Combined Use of Didanosine (2',3'-Dideoxyinosine; ddI) and Lentinan in HIV-Positive Patients

HIV Infections Clinical Trial

Official title:Phase II/III Study of the Tolerance and Efficacy of Combined Use of Didanosine (2',3'-Dideoxyinosine; ddI) and Lentinan in HIV-Positive Patients

Status Active, not recruiting

Clinical Trial Summary

To determine the tolerance and side effects of a combination of lentinan and didanosine
(ddI) in comparison with ddI alone. To determine whether the combination of lentinan and ddI
produces a significant immunorestorative effect within the study observation period (6-12
months) as measured by an increase in one or more of the following: neutrophil count and
activity, T-cell subsets, and a decrease in p24 antigen.

Clinical Trial Description

Patients are treated with daily oral ddI for 6 weeks, then are randomized to ddI in
combination with intravenous lentinan or placebo (administered once weekly) for 26 weeks.
Patients who are already stabilized on 400 mg/day ddI will proceed directly to
randomization. Following completion of the combination therapy, patients may be offered 26
additional weeks of therapy on an optional basis.
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